Functional Vision and Quality of Life in a Modern Society - With Emphasis on Myopia and Cerebral Visual Impairment Among Youth

NCT07653074 | Recruiting

• 1 other identifier: Region Örebro County
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Society has become increasingly digital, and many everyday services have been replaced by digital self-service solutions. This puts greater demands on our vision and our ability to interpret what we see. At the same time, the number of children with nearsightedness (myopia) has increased rapidly. In some parts of Asia, as many as 60-70% of students in seventh grade are nearsighted (1), and a similar trend may develop in Europe. Nearsightedness is becoming a growing challenge in pediatric eye care. High myopia can lead to complications that require early detection and prevention. There are now several ways to slow down its progression, such as special contact lenses, glasses, and eye drops (2). However, the scientific evidence for these treatments varies, and there are currently no national or Nordic guidelines on how to use them. In addition, myopia may have a major impact on children's quality of life. Currently, there is no validated Swedish questionnaire that measures vision related quality of life across all age groups in children and adolescents. To address this, researchers in the United States developed the Pediatric Eye Questionnaire (PedEyeQ) in 2019 (3). It is already available in English and Spanish and takes into account both the child's and the parent's perspectives on vision and daily life. The aim of this study is to translate, culturally adapt and test the PedEyeQ in Swedish children and adolescents, and to investigate how common refractive errors, especially nearsightedness - are today compared to 20-30 years ago. The study will include 300 healthy children and adolescents aged 0-17 years, divided into three age groups: 0-4 years, 5-11 years, and 12-17 years. Participants will be recruited through child health centers, preschools, and schools in the Örebro region. All participants will visit the eye clinic for a detailed eye examination, including:

• Testing distance and near visual acuity
• Measuring eye refraction (with and without eye drops that temporarily relax the eye's focusing muscles)
• Imaging the retina using Optical Coherence Tomography (OCT)
• Measuring eye length and corneal shape
• Checking eye pressure and contrast sensitivity Children and parents will also answer questions about how the child's vision affects everyday life and wellbeing. For the youngest children (0-4 years), only parents will answer the questions. The PedEyeQ will be translated into Swedish following the International Society for Pharmacoeconomics and Outcome Research (ISPOR) (4) guidelines to make sure it is culturally relevant and easy to understand. The Swedish version will then be tested to ensure it is accurate and reliable. All information collected in the study will be stored securely and anonymously. The results will also be compared with data from a similar cohort conducted in the 1990s to see if vision problems have become more common over time (5). This project will provide new knowledge about children's vision and quality of life in Sweden. A validated Swedish version of the PedEyeQ can be used both in healthcare and research to better understand how vision affects children's daily lives. The study will also offer updated information on the frequency of refractive errors among Swedish children and adolescents - knowledge that is essential for developing preventive strategies and improving eye care for the future.

Conditions

Myopia; Quality of Life

Keywords

Quality of life; myopia; Sweden

Outcome Measures

Primary Outcomes (1)

• Prevalence of refractive errors

  1 day

Study Arms (1)

Healthy children 0-17 years

The study group will consist of 300 participants aged 0-17 years, divided into the following age-based subgroups corresponding to the PedEyeQ versions: 0-4 years, 5-11 years, and 12-17 years, with 100 participants in each group. Efforts will be made to ensure that sex distribution, ethnicity, socioeconomic status, and birth parameters reflect those of the general population. Recruitment will primarily take place through child health centers, preschools, and schools in Örebro and surrounding areas.

Diagnostic Test: ophthalmological examination

Interventions

ophthalmological examination DIAGNOSTIC_TEST

The examination will include: Assessment of distance and near visual acuity, Autorefraction measurements both with and without cycloplegia (i.e., after administration of dilating eye drops to temporarily suspend accommodation and obtain accurate refraction values), Optical Coherence Tomography (OCT) to measure retinal thickness and to detect potential pathology such as edema, deposits, or thinning, Axial length measurement, Non-invasive corneal mapping of corneal thickness, curvature, and refractive power using Pentacam,Measurement of intraocular pressure using a non-contact, non-anesthetic method, and Assessment of contrast sensitivity. It will also include questionnaires as the PedEyeQ described earlier, the PedQoL.

Healthy children 0-17 years

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study group will be selected from randomised preschools, and schools in Örebro and surrounding areas and we aim to collect a cohort as equal as possible compared to health children in general. Efforts will be made to ensure that sex distribution, ethnicity, socioeconomic status, and birth parameters reflect those of the general population.

You may qualify if:

• Healthy children

You may not qualify if:

• Children with ophthalmological diagnosis followed frequently by the ophthalmological clinic

Sponsors & Collaborators

• Region Örebro County: lead
• Sahlgrenska University Hospital: collaborator
• Göteborg University: collaborator

Study Sites (1)

Örebro university hospital

Örebro, Sweden

RECRUITING

Related Publications (5)

• Gronlund MA, Andersson S, Aring E, Hard AL, Hellstrom A. Ophthalmological findings in a sample of Swedish children aged 4-15 years. Acta Ophthalmol Scand. 2006 Apr;84(2):169-76. doi: 10.1111/j.1600-0420.2005.00615.x.

  PMID: 16637831 BACKGROUND

• Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.

  PMID: 15804318 BACKGROUND

• Hatt SR, Leske DA, Castaneda YS, Wernimont SM, Liebermann L, Cheng-Patel CS, Birch EE, Holmes JM. Development of Pediatric Eye Questionnaires for Children With Eye Conditions. Am J Ophthalmol. 2019 Apr;200:201-217. doi: 10.1016/j.ajo.2019.01.001. Epub 2019 Jan 14.

  PMID: 30653960 BACKGROUND

• Cooper J, Tkatchenko AV. A Review of Current Concepts of the Etiology and Treatment of Myopia. Eye Contact Lens. 2018 Jul;44(4):231-247. doi: 10.1097/ICL.0000000000000499.

  PMID: 29901472 BACKGROUND

• Li SM, Wei S, Atchison DA, Kang MT, Liu L, Li H, Li S, Yang Z, Wang Y, Zhang F, Wang N. Annual Incidences and Progressions of Myopia and High Myopia in Chinese Schoolchildren Based on a 5-Year Cohort Study. Invest Ophthalmol Vis Sci. 2022 Jan 3;63(1):8. doi: 10.1167/iovs.63.1.8.

  PMID: 34989760 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Alexandra UC Wrede, MD

CONTACT

+358400791907; alexandra.wrede@regionorebrolan.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start: October 27, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2029
• Last Updated: June 17, 2026

Record last verified: 2025-10

Locations

SE (1)